QSSK-RAA-Regulatory Affairs Assistant

Job Purpose

• To ensure business compliance to regulations and standards according to the Good Warehousing Practice as outlined by the Pharmacy and Poisons Board (PPB) and adherence to Standard Operating Procedures that govern compliance to ISO 9001:2015.

Key Responsibilities

Regulatory Compliance

• Apply for import permits according to the Pharmacy and Poisons Board (PPB) rules.
• Ensure all documentation required for official records is filed and easily retrievable.

Audits & Non-Conformance Management

• Ensure that non-conformances are initiated, reviewed, and evaluated.
• Ensure non-conformances are closed within 30 days of initiation.
• Prepare non-conformance trends and reports.

Environmental Management

• Participate in the implementation of departmental and site Environmental Management System (EMS) objectives.
• Ensure EMS objectives are monitored and measured.

Documentation & Reporting

• Handle all documentation needed for official records in line with established SOPs and working instructions.
• Prepare weekly reports on regulatory activities.
• Perform any other duties as assigned by Management from time to time.

Qualification and Experience

Education

• Diploma in Pharmacy, Clearing and Forwarding, Information Technology, or a related field.

Experience

• Experience in document management is required.
• Prior exposure to regulatory affairs or compliance roles is an added advantage.

Technical Skills

• Computer literacy, including proficiency in Microsoft Office applications.
• Knowledge of document management systems.
• Understanding of regulatory requirements (PPB, ISO 9001:2015) is an added advantage.

Core Competencies

• Strong attention to detail and organizational skills.
• Ability to work under pressure and meet deadlines.
• Excellent communication and interpersonal skills.
• Integrity and ability to handle confidential information.
• Team player with a proactive attitude.